Primeprint Splint ST 1000g

GUDID EDET044151

DETAX GmbH

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• Primary Device ID: EDET044151
• NIH Device Record Key: c6624457-b268-4d87-af96-abdfaff9bf4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primeprint Splint ST 1000g
• Version Model Number: 04415
• Company DUNS: 343947949
• Company Name: DETAX GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDET044151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232448

FDA Product Code

• KMY: Positioner, Tooth, Preformed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-02
• Device Publish Date: 2023-10-25

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